Alveolar Ridge EnlargementNCT05426616
Titanium Reinforced d-PTFE Membrane Versus Collagen Membrane For Guided Bone Regeneration
A study testing collagen membrane (Creos Xenoprotect , Nobel Biocare AB, Göteborg, Sweden) and titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden) in people with Alveolar Ridge Enlargement, run by University Ghent at 3 sites in Belgium.
Trial summary
After tooth extraction, shrinkage of the bone is expected with 50% reduction of alveolar width. Patients at least 3months after tooth extraction and in need of single oral implant placement in the anterior maxilla with both neighboring teeth present, were invited to participate in an inter-subject RCT if insufficient… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Enlargement
- What is being tested?
- collagen membrane (Creos Xenoprotect , Nobel Biocare AB, Göteborg, Sweden) and titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Jun 2022to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al. 1972)
- presence of a single tooth gap in the anterior maxilla (15-25) with both neighboring teeth present
- failing tooth at least 3 months earlier removed
Who cannot join
- systemic diseases
- smoking; (history of) periodontal disease
- untreated caries lesions
- pregnancy (will be explicitly asked)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jan Cosyn, Professor contact
Belgium3 sites, 3 recruiting
- Recruiting
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, 9000
Jan Cosyn, Professor, 093324017, jan.cosyn@ugent.be
- Recruiting
Centrum voor Parodontologie en Orale Implantologie
Zottegem, Oost-Vlaanderen, 9620
Jan Cosyn, Professor, 0496100121, jan.cosyn@ugent.be
Thomas De Bruyckere, Doctor
- Recruiting
Parodonto
Zwijnaarde, Oost-Vlaanderen, 9052
Faris Younes, Doctor, faris.younes@ugent.be
About this study
Official title: A Randomized Controlled Trial Comparing Titanium Reinforced d-PTFE Membrane to Collagen Membrane for Guided Bone Regeneration at Single Tooth Sites in the Premaxilla: a Clinical, CBCT and Histomorphometric Analysis
After tooth extraction, shrinkage of the bone is expected with 50% reduction of alveolar width. Patients at least 3months after tooth extraction and in need of single oral implant placement in the anterior maxilla with both neighboring teeth present, were invited to participate in an inter-subject RCT if insufficient residual alveolar bone was left for proper implant placement. Guided bone regeneration has been used to recreate bone volume. A combination of xenogenous bone (Creos Xenogain , Nobel Biocare AB, Göteborg, Sweden) and autologous bone chips in a 1:1 ratio, is protected by a membrane fixated in the bone. A resorbable, non-stable membrane (Creos Xenoprotect, Nobel Biocare AB, Göteborg, Sweden) or non-resorbable titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden) can be used.
This study aims to compare the effectivity of the two membranes by measuring changes in bone dimensions. The resorbable membrane has the advantage that it does not need to be removed, whereas the titanium reinforced membrane can protect the rebuilt volume better against external forces.
Read more
Patients start to take systemic antibiotics (Amoxicilline 1g) and anti-inflammatory medication (ibuprofen 600 mg) 1h pre-operatively. Following local anesthesia (Septanest special, Septodont, Saint Maur des Fossés, France) and oral disinfection (Corsodyl mouth rinse, GSK, Wavre, Belgium), a large mucoperiosteal flap will be raised with two vertical releasing on each side of the edentulous space and at the distal aspect of the second neighboring tooth. The flap extends to the base of the alveolar process to allow full access. Autogenous bone chips are harvested from the retromolar area with bone scrapers and/or from an edentulous site using ACM bone collector (NeoBiotech, Guro-gu Seoul, Republic of Korea). DBBM particles (Xenogain, Nobel Biocare, Göteborg, Sweden) soaked in blood are mixed with autogenous bone chips to a ratio of 1/1. After having made multiple bone perforations at the buccal aspect of the recipient site, the mixture of bone chips and DBBM is applied. An individualized collagen membrane (Xenoprotect, Nobel Biocare, Göteborg, Sweden) or a non-resorbable titanium reinforced d-PTFE membrane is attached on top using membrane fixation pins. Prior to fixation of the final pin, bone grafting material is additionally applied from the lateral aspect to ensure that it is properly packed under the membrane and fully stable. Following release of the periosteum and muscle insertion, tension-free primary wound closure is achieved with horizontal mattress 4/0 titanium reinforced d-PTFE sutures and single 6/0 monofilament sutures. Patients continue the intake of antibiotics and anti-inflammatory medication for 7 days and use an oral mouthrinse during 2 weeks. Sutures are removed after 2 weeks, and an implant is installed after 9 months following 3D implant planning.
A sample size calculation indicated 17 patients to be included per group. To compensate for one drop-out, 18 patients would be treated with collagen membrane and 18 would be treated with titanium reinforced d-PTFE.
Changes in horizontal bone dimensions over time is the primary outcome. Prior to surgery, immediately after GBR, at 9 months, at 3 years and 5 years a CBCT is taken. Every CBCT is superimposed to the baseline CBCT in designated software and horizontal buccal bone dimensions are measured.
Secondary outcomes include
- Membrane exposure
- Intrasurgical changes in bone crest width over time
- Intrasurgical assessment of bone quality at implant placement at the palatal, midcrestal and buccal aspect
- Need for re-grafting at implant placement
- Need for soft tissue grafting at implant placement
- Need for augmentation of keratinized mucosa at implant placement
- Volumetric increase in buccal bone at 3 and 5 years
- Peri-implant health at 3 and 5 years by means of intra-oral radiograph
- Esthetic outcomes at 3 and 5 years
- Histomorphometric analysis on 20 cases (10 per group)
- Conditions
- Alveolar Ridge Enlargement
- Being tested
- collagen membrane (Creos Xenoprotect , Nobel Biocare AB, Göteborg, Sweden), titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden)
- Keywords
- Guided bone regeneration, Resorbable collagen membrane, Titanium reinforced d-PTFE membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagen membrane (Creos Xenoprotect , Nobel Biocare AB, Göteborg, Sweden)Device
A mucoperiosteal flap will be raised with two vertical releasing on each side of the edentulous space. Autogenous bone chips are harvested from the retromolar area with bone scrapers and/or from an edentulous site using ACM bone collector. DBBM particles soaked in blood are mixed with autogenous bone chips to a ratio of 1:1. After having made multiple bone perforations at the buccal aspect of the recipient site, the mixture of bone chips and DBBM is applied. An individualized collagen membrane is attached on top using membrane fixation pins. Prior to fixation of the final pin, bone grafting material is additionally applied from the lateral aspect to ensure that it is properly packed under the membrane and fully stable. Following release of the periosteum and muscle insertion, tension-free primary wound closure is achieved.
titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden)Device
A mucoperiosteal flap will be raised with two vertical releasing on each side of the edentulous space. Autogenous bone chips are harvested from the retromolar area with bone scrapers and/or from an edentulous site using ACM bone collector. DBBM particles soaked in blood are mixed with autogenous bone chips to a ratio of 1:1. After multiple bone perforations at the buccal aspect of the recipient site, the mixture of bone chips and DBBM is applied.A titanium reinforced d-PTFE membrane is attached on top using membrane fixation pins. Care is taken to leave a distance of at least 1 mm between the membrane and neighboring teeth. Prior to fixation of the final pin, bone grafting material is additionally applied from the lateral aspect to ensure that it is properly packed under the membrane and fully stable. Following release of the periosteum and muscle insertion, tension-free primary wound closure is achieved. The membrane is removed after 9 months, prior to implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Control group: Collagen membrane | Active comparator | (Xenoprotect, Nobel Biocare, Göteborg, Sweden) Receives: Device: collagen membrane (Creos Xenoprotect , Nobel Biocare AB, Göteborg, Sweden) |
| Test group: titanium reinforced d-PTFE membrane | Experimental | (Creos Syntoprotect,Nobel Biocare AB, Göteborg, Sweden) Receives: Device: titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in horizontal bone dimensions over time
At T0, t1, t2, t3 and t4 a CBCT is taken. Every CBCT is superimposed to the baseline CBCT in designated software and horizontal buccal bone dimensions are measured at 1 mm, 3 mm, 5 mm, 7 mm and 9 mm from the crest. The changes from baseline in horizontal bone dimensions at the different levels is calculated.
Measured: baseline = t0, immediately after GBR = t1, at 9 months= t2, 3 years = t3 and 5 years=t4
Secondary outcomes (10)
Membrane exposure
Wound dehiscence after GBR could expose the membrane. Clinically assessment if the membrane is coming exposed through the mucosa during the healing period of 9months after placement, results in a % of cases with membrane exposure.
Measured: During the 9 months of healing after GBR.
Intrasurgical changes in bone crest width over time
Measurement of the bone crest width intrasurgically, after mucoperiosteal flap preparation.
Measured: Baseline, after GBR and 9 months after GBR during implant placement procedure.
Bone type: clinician perception (hand feel resistance)
Classification by Misch. Tactile sense of the surgeon in the assessment of bone density, groups (D1-D4). D1 bone type = homogenous dense cortical. D2 = combination of dense-to-porous cortical bone on the crest and trabecular bone from 40% to 60% on the inside. D3 = thinner porous cortical bone on the crest and fine trabecular bone within the ridge. D4 = bone has the least trabecular density with little or no cortical crestal bone.
Measured: t2 = 9 months after GBR, at implant placement
Bone dimensions vertically and horizontally
Bone volume assessment for the ideal restorative driven position of the implant after 9 months of healing, reporting if insufficient bone was leading to additional bone grafting simultaneously at the time of implant placement.
Edentulous bone ridge classification followed three-dimensional (3D) quantity of alveolar bone shape and volume based on CBCT measurements. (UCLA) Classification: Type I: sufficient alveolar shape for implants, Type II: insufficient alveolar bone on the buccal site, Type III: knife edge shape with sufficient alveolar bone height, Type IV: insufficient alveolar bone height.
Measured: t2 = 9 months after GBR, at implant placement
Buccal soft tissue thickness
Buccal concavity after resorption of the soft tissue, can cause additional need for soft tissue augmentation procedure. The need for soft tissue augmentation will be scored by the clinician. The thickness of the soft tissues was measured (in mm) at t2 (9months after GBR), t3 (3 years) and T4 (5years) perpendicular to the long axis of the implant. Buccal soft tissue thickness was measured from the bone-soft tissue interface to the buccal soft tissue outline at the same levels as horizontal bone dimensions.
Measured: t2 = 9 months after GBR, at implant placement
Buccal keratinized soft tissue width
The width of the keratinized soft tissues buccally was measured clinically (in mm) at t2 (9months after GBR), t3 (3 years) and T4 (5years) from the gingival margin to mucogingival junction. Minimally 3 mm provides a prosthetic friendly environment, allows oral hygiene maintenance, resists recession, and enhances esthetic blending. If less than 3mm, additional soft tissue grafting can be indicated.
Measured: t2 = 9 months after GBR, at implant placement
Volumetric changes in buccal bone at 3 and 5 years
Volumetric measurement with CBCT by superimposed the images in specialized software (OnDemand3D, Cybermed Inc., Seoul, South-Korea). Changes in bone volume are calculated by subtracting.
Measured: baseline = t0, immediately after GBR = t1, at 9 months= t2, 3 years = t3 and 5 years=t4
Peri-implant health
Evaluation by means of intra-oral radiograph of bone level.
Measured: At 3 and 5 years
Pink Esthetic Score
The PES awards 7 parameters: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue colour, soft tissue texture. Each parameter is assessed with a 0-1-2 score, yielding a PES score ranging from 0 (worst aesthetic outcome) to 14 (perfect aesthetic outcome).
Measured: At 3 and 5 years
Histomorphometric analysis
On 20 cases (10 per group), with a trepan bur, bone samples are removed and collected from implant site at 9 months right before implant placement, for measurements: Vital bone fraction, biomaterial fraction, connective tissue fraction and cell counts.
Measured: t2 = 9 months after GBR, at implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alveolar Ridge EnlargementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Cosyn, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426616
- Sponsor's protocol ID
- BC-11825
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hindryckx M, De Bruyckere T, Hitz-Steiger S, Seyssens L, Shtino R, Younes F, Thoma D, Cosyn J. A Multi-Center RCT Comparing Titanium-Reinforced dPTFE Membrane to Collagen Membrane in Horizontal Bone Augmentation at Single Sites in the Anterior Maxilla: Clinical and Histological Outcomes. Clin Implant Dent Relat Res. 2025 Dec;27(6):e70097. doi: 10.1111/cid.70097.
PubMed 41185408Hindryckx M, De Bruyckere T, De Buyser S, Seyssens L, Shtino R, Younes F, Cosyn J. A Multi-Centre Randomised Controlled Trial Comparing dPTFE Membrane to Collagen Membrane in Lateral Bone Augmentation at Single Sites in the Anterior Maxilla: 1-Year Results. J Clin Periodontol. 2025 Aug;52(8):1136-1146. doi: 10.1111/jcpe.14174. Epub 2025 Apr 29.
PubMed 40298001
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Titanium Reinforced d-PTFE Membrane to Collagen Membrane for Guided Bone Regeneration at Single Tooth Sites in the Premaxilla: a Clinical, CBCT and Histomorphometric Analysis
- ClinicalTrials.gov ID
- NCT05426616
- Acronym / sponsor ID
- BC-11825
- Conditions
- Alveolar Ridge Enlargement
- Keywords
- Guided bone regeneration, Resorbable collagen membrane, Titanium reinforced d-PTFE membrane
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After tooth extraction, shrinkage of the bone is expected with 50% reduction of alveolar width. Patients at least 3months after tooth extraction and in need of single oral implant placement in the anterior maxilla with both neighboring teeth present, were invited to participate in an inter-subject RCT if insufficient residual alveolar bone was left for proper implant placement. Guided bone regeneration has been used to recreate bone volume. A combination of xenogenous bone (Creos Xenogain , Nobel Biocare AB, Göteborg, Sweden) and autologous bone chips in a 1:1 ratio, is protected by a membrane fixated in the bone. A resorbable, non-stable membrane (Creos Xenoprotect, Nobel Biocare AB, Göteborg, Sweden) or non-resorbable titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden) can be used.
This study aims to compare the effectivity of the two membranes by measuring changes in bone dimensions. The resorbable membrane has the advantage that it does not need to be removed, whereas the titanium reinforced membrane can protect the rebuilt volume better against external forces.
Patients start to take systemic antibiotics (Amoxicilline 1g) and anti-inflammatory medication (ibuprofen 600 mg) 1h pre-operatively. Following local anesthesia (Septanest special, Septodont, Saint Maur des Fossés, France) and oral disinfection (Corsodyl mouth rinse, GSK, Wavre, Belgium), a large mucoperiosteal flap will be raised with two vertical releasing on each side of the edentulous space and at the distal aspect of the second neighboring tooth. The flap extends to the base of the alveolar process to allow full access. Autogenous bone chips are harvested from the retromolar area with bone scrapers and/or from an edentulous site using ACM bone collector (NeoBiotech, Guro-gu Seoul, Republic of Korea). DBBM particles (Xenogain, Nobel Biocare, Göteborg, Sweden) soaked in blood are mixed with autogenous bone chips to a ratio of 1/1. After having made multiple bone perforations at the buccal aspect of the recipient site, the mixture of bone chips and DBBM is applied. An individualized collagen membrane (Xenoprotect, Nobel Biocare, Göteborg, Sweden) or a non-resorbable titanium reinforced d-PTFE membrane is attached on top using membrane fixation pins. Prior to fixation of the final pin, bone grafting material is additionally applied from the lateral aspect to ensure that it is properly packed under the membrane and fully stable. Following release of the periosteum and muscle insertion, tension-free primary wound closure is achieved with horizontal mattress 4/0 titanium reinforced d-PTFE sutures and single 6/0 monofilament sutures. Patients continue the intake of antibiotics and anti-inflammatory medication for 7 days and use an oral mouthrinse during 2 weeks. Sutures are removed after 2 weeks, and an implant is installed after 9 months following 3D implant planning.
A sample size calculation indicated 17 patients to be included per group. To compensate for one drop-out, 18 patients would be treated with collagen membrane and 18 would be treated with titanium reinforced d-PTFE.
Changes in horizontal bone dimensions over time is the primary outcome. Prior to surgery, immediately after GBR, at 9 months, at 3 years and 5 years a CBCT is taken. Every CBCT is superimposed to the baseline CBCT in designated software and horizontal buccal bone dimensions are measured.
Secondary outcomes include
- Membrane exposure
- Intrasurgical changes in bone crest width over time
- Intrasurgical assessment of bone quality at implant placement at the palatal, midcrestal and buccal aspect
- Need for re-grafting at implant placement
- Need for soft tissue grafting at implant placement
- Need for augmentation of keratinized mucosa at implant placement
- Volumetric increase in buccal bone at 3 and 5 years
- Peri-implant health at 3 and 5 years by means of intra-oral radiograph
- Esthetic outcomes at 3 and 5 years
- Histomorphometric analysis on 20 cases (10 per group)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group: Collagen membrane | Active comparator | Device: collagen membrane (Creos Xenoprotect , Nobel Biocare AB, Göteborg, Sweden)(Xenoprotect, Nobel Biocare, Göteborg, Sweden) |
| Test group: titanium reinforced d-PTFE membrane | Experimental | Device: titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden)(Creos Syntoprotect,Nobel Biocare AB, Göteborg, Sweden) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al. 1972)
- presence of a single tooth gap in the anterior maxilla (15-25) with both neighboring teeth present
- failing tooth at least 3 months earlier removed
Key exclusion criteria (4 listed)
- systemic diseases
- smoking; (history of) periodontal disease
- untreated caries lesions
- pregnancy (will be explicitly asked)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collagen membrane (Creos Xenoprotect , Nobel Biocare AB, Göteborg, Sweden)A mucoperiosteal flap will be raised with two vertical releasing on each side of the edentulous space. Autogenous bone chips are harvested from the retromolar area with bone scrapers and/or from an edentulous site using ACM bone collector. DBBM particles soaked in blood are mixed with autogenous bone chips to a ratio of 1:1. After having made multiple bone perforations at the buccal aspect of the recipient site, the mixture of bone chips and DBBM is applied. An individualized collagen membrane is attached on top using membrane fixation pins. Prior to fixation of the final pin, bone grafting material is additionally applied from the lateral aspect to ensure that it is properly packed under the membrane and fully stable. Following release of the periosteum and muscle insertion, tension-free primary wound closure is achieved. | Device | Control group: Collagen membrane |
| titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden)A mucoperiosteal flap will be raised with two vertical releasing on each side of the edentulous space. Autogenous bone chips are harvested from the retromolar area with bone scrapers and/or from an edentulous site using ACM bone collector. DBBM particles soaked in blood are mixed with autogenous bone chips to a ratio of 1:1. After multiple bone perforations at the buccal aspect of the recipient site, the mixture of bone chips and DBBM is applied.A titanium reinforced d-PTFE membrane is attached on top using membrane fixation pins. Care is taken to leave a distance of at least 1 mm between the membrane and neighboring teeth. Prior to fixation of the final pin, bone grafting material is additionally applied from the lateral aspect to ensure that it is properly packed under the membrane and fully stable. Following release of the periosteum and muscle insertion, tension-free primary wound closure is achieved. The membrane is removed after 9 months, prior to implant placement. | Device | Test group: titanium reinforced d-PTFE membrane |
Primary outcome
Changes in horizontal bone dimensions over time
Time frame: baseline = t0, immediately after GBR = t1, at 9 months= t2, 3 years = t3 and 5 years=t4
At T0, t1, t2, t3 and t4 a CBCT is taken. Every CBCT is superimposed to the baseline CBCT in designated software and horizontal buccal bone dimensions are measured at 1 mm, 3 mm, 5 mm, 7 mm and 9 mm from the crest. The changes from baseline in horizontal bone dimensions at the different levels is calculated.
10 secondary outcomes
Membrane exposure
Time frame: During the 9 months of healing after GBR.
Intrasurgical changes in bone crest width over time
Time frame: Baseline, after GBR and 9 months after GBR during implant placement procedure.
Bone type: clinician perception (hand feel resistance)
Time frame: t2 = 9 months after GBR, at implant placement
Bone dimensions vertically and horizontally
Time frame: t2 = 9 months after GBR, at implant placement
Buccal soft tissue thickness
Time frame: t2 = 9 months after GBR, at implant placement
Buccal keratinized soft tissue width
Time frame: t2 = 9 months after GBR, at implant placement
Volumetric changes in buccal bone at 3 and 5 years
Time frame: baseline = t0, immediately after GBR = t1, at 9 months= t2, 3 years = t3 and 5 years=t4
Peri-implant health
Time frame: At 3 and 5 years
Pink Esthetic Score
Time frame: At 3 and 5 years
Histomorphometric analysis
Time frame: t2 = 9 months after GBR, at implant placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Derived from this study: PubMed 41185408Hindryckx M, De Bruyckere T, Hitz-Steiger S, Seyssens L, Shtino R, Younes F, Thoma D, Cosyn J. A Multi-Center RCT Comparing Titanium-Reinforced dPTFE Membrane to Collagen Membrane in Horizontal Bone Augmentation at Single Sites in the Anterior Maxilla: Clinical and Histological Outcomes. Clin Implant Dent Relat Res. 2025 Dec;27(6):e70097. doi: 10.1111/cid.70097.
- Derived from this study: PubMed 40298001Hindryckx M, De Bruyckere T, De Buyser S, Seyssens L, Shtino R, Younes F, Cosyn J. A Multi-Centre Randomised Controlled Trial Comparing dPTFE Membrane to Collagen Membrane in Lateral Bone Augmentation at Single Sites in the Anterior Maxilla: 1-Year Results. J Clin Periodontol. 2025 Aug;52(8):1136-1146. doi: 10.1111/jcpe.14174. Epub 2025 Apr 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Cosyn, Professor contact
Jan Cosyn, Professor principal investigator
University Ghent
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collagen membrane (Creos Xenoprotect , Nobel Biocare AB, Göteborg, Sweden) and titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden) in people with Alveolar Ridge Enlargement, run by University Ghent at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Cosyn, Professor (093324017, jan.cosyn@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in horizontal bone dimensions over time (time frame: baseline = t0, immediately after GBR = t1, at 9 months= t2, 3 years = t3 and 5 years=t4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05426616, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.